Aldactazide 30 Tablets

QUALITATIVE AND QUANTITATIVE COMPOSITION     

Excipients:

See section 6.1 for excipients.

Spironolactone

Hydrochlorothiazide

4. CLINICAL FEATURES

4.1. Therapeutic indications

• Conjunctive heart failure, liver cirrhosis with ascites and / or edema, nephrotic syndrome and other edematous conditions,

• essential hypertension,

• in patients with digital field; it is used when other diuretics are insufficient or unsuitable to achieve the electrolyte balance

.

4.2 Posology and method of administration

Posology / frequency and duration of administration:

Edema (congestive heart failure, liver cirrhosis or nephrotic syndrome): The ALDACTAZIDE® isgeneral dose of 100 daily for each of spironolactone and hydrochlorothiazide, which can be taken in a single dose or in divided doses. mg. However, 25 mg to 200 mg dose can be adjusted according to the response of the patient.

With the ALDACTAZIDE® use of, diuresis occurs immediately and continues for 2-3 days after discontinuation of the drug due to the prolonged effect of the spironolactone compound.

Essential hypertension: Although the dosage varies depending on the results of each component titer; The daily optimum dose for spironolactone and hydrochlorothiazide for many patients is 50 to 100 mg, which can be taken in a single dose or in divided doses.

Since spironolactone is sufficient to reduce the negative effect of hydrochlorothiazide on potassium, the ALDACTAZINEduring long-term treatment of hypertension or many types of edema ® use of potassium supplements withis not recommended.  

Method of administration: It

should be taken orally.

ALDACTAZIDE®is recommended to be taken once a day with meals.

Additional information on special populations:

Renal insufficiency: Acute renal failure, marked disruption in the mechanism of kidney excretion should not be used.

Hepatic impairment: It should not be used in case of acute and severe hepatic impairment.

Pediatric population:

ALDACTAZIDE children® in Although there are no clinical studies using, the daily dose can be given in divided doses of 3 mg of spironolate per kilogram of body weight.

Efficacy and safety have not been proven in pediatric patients.

Geriatric population: It

is recommended to start treatment with the lowest dose and the dose may be gradually increased to obtain maximum benefit. Care must be taken in serious liver and kidney disorders that may alter drug metabolism and excretion.

4.3. Contraindications

ALDACTAZIDE®

• Anuria,

• Acute renal failure,

• Significant impairment in the mechanism of excretion of the kidneys,

• Hyperkalemia,

• Acute or severe liver failure,

• Addison's disease,

• Spironolactone, thiazide diuretics, sulfonamide derivative drugs or ALDACTAZIDE® other auxiliary substances contained in

is contraindicated.

4.4. Special Warnings and Precautions

in® potassium-sparing diuretics during use ALDACTAZIDE inhibitors, angiotensin II antagonists, aldosterone antagonists, potassium supplements, salt substitution rich diet or potassium potassium should not be applied since they may cause severe hyperkalemia. Excessive ALDACTAZIDE potassium intake may cause hyperkalemia in the patient using. Spironolactone, when used in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) such as ACE inhibitors or indomethacin, may cause severe hyperkalemia, even if diuretic is present. ALDACTAZIDE Particular attention should be paid to the use ofwith said drugs.

If hypokalamia is suspected (paresthesia, muscle weakness, fatigue, bardikardi, shock), an electrocardiogram (ECG) should be performed. However, since mild hypercalamia cannot be detected by ECG changes, serum potassium levels should also be checked.

If hyperkalemia develops, ALDACTAZIDE should be discontinued immediately and, if necessary, measures should be taken to reduce serum potassium to normal level (such as calcium chloride solution, intravenous administration of sodium bicarbonate solution and / or oral or parenteral administration of glucose with fast acting insulin preparations). These applications should be repeated if necessary. Cationic modifying resins such as sodium polystyrene sulfonates should be administered orally or rectally. Dialysis may be required for ongoing hyperkalamia.

In cases where spironolactone is used in combination with ammonium chloride or cholestramine, edil hyperkalemic metabolic acidosis, has been reported in patients.

ALDACTAZIDE in patients with hepatic impairment as minor changes in fluid and electrolyte balance may cause hepatic coma® should be used with caution.

Hyperkalemia may occur in patients with renal dysfunction or excessive potassium intake and may lead to fatal cardiac disorders.

ALDACTAZIDE because thiazides may cause the ascites in patients with severe renal failure® should be used with caution in this patient group. The effect of accumulation of the drug can be seen in patients with renal insufficiency.

Thiazides may increase or potentiate the effect of other antihypertensive drugs.

Patients with or without a history of allergy or bronchial asthma may develop allergies to thiazides.

It has been reported that sulfonamide derivatives, including thiazides, activate or exacerbate systemic lupus erythematosus.

ALDACTAZIDE may cause a temporary increase of BUN. When treatment is terminated, it returns to its normal level. BUN may continue to increase if there is already a renal failure.

Some decompensated hepatic cirrhosis patients have been reported to have reversible hyperchloromic metabolic acidosis, usually accompanied by hyperkalamin, even if they have normal renal function.

Dry mouth, thirst, characterized by lethargy and drowsiness, dilüzyonal hyponatremia can be detected with low serum levels of sodium, ALDACTAZIDE be® seen when used togetherand other diuretics. Dilutional hyponatremia may occur in patients with edema in hot weather. The reduction of water instead of sodium supplementation is a more suitable treatment, except in cases such as life-threatening hyponatremia.

Low-salt syndrome, manifested by confusion similar to that seen in hepatic comararely ALDACTAZIDE® , canbe seen duringuse. This syndrome is different from dilusion hyponatremia because it does not occur with obvious fluid involvement. ALDACTAZIDE for treatment® should be discontinued and sodium should be given.

Thiazides may cause hyperuricemia and the formation of gout attacks in some patients. It has also been shown to increase the excretion of magnesium in the urine that may cause hypomagnesemia. Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.

Thiazides can aggravate diabetes and change the need for insulin. Diabetes, which is hidden during thiazide treatment, may become apparent.

Thiazides may reduce urinary calcium excretion. Thiazides may cause intermittent and very mild serum calcium increase. Significant hypercalcemia may be indicative of latent hyperparathyroidism. Thiazide uptake should be discontinued before performing parathyroid function tests. Pathologic alterations in hypercalcemia and hypophosphatemia and parathyroid glands can be seen during long-term thiazide treatment.

Gynecomastia development can be seen with the use of spironolactone,ALDACTAZIDE  in®. return to normal upon discontinuation of treatment However, it was observed that gynecomastia did not disappear.

4.5. Interactions with other medicinal products and other forms of interaction

ALDACTAZIDE® has been shown to increase the half-life of digoxin. This increases serum digoxin concentration followed by digitalis toxicity. When digoxin is taken with spironolactone, it may be necessary to lower the dose of digitalization. Such patients should be carefully monitored.

The ALDACTAZIDE treatment, as it may increase the effects of antihypertensive drugs® is dose of these drugs may need to be adjusted when added to the. Especially in patients with renal impairment, ACE inhibitors ALDACTAZIDE reduces aldosterone production® should not be used routinely with it.

Combination of carbenoxolone and spironolactone may reduce the efficacy of both agents.

Non-steroidal anti-inflammatory drugs reduce the natriuretic activity of diuretics by inhibiting prostaglandin intrarenal synthesis.

Simultaneous use of lithium and thiazides may reduce lithium clearance, which may lead to intoxication.

Both spironolactone and hydrochlorothiazide reduce the vascular response to neuroprephrine.ALDACTAZIDE® Caution should be exercised if patients treated with have to take local or general anesthesia.

The use of alcohol, barbiturates or narcotics ALACTASIA® together with may lead to the formation of orthostatic hypotension.

Antidiabetic drugs (insulin, or orally taken): Antidiabetic drugs may require dosage adjustment.

Corticosteroids, ACTH: Intensive electrolyte consumption, especially hypokalemia, may occur.

Musculoskeletal relaxants (such as tubocurarine): may increase the response to muscle relaxants.

Aspirin, indomethacin and mefenamic acid have been shown to reduce the diuretic effect of spironolactone.

Spironolactone enhances the metabolism of antipyrine.

The absorption of some drugs containing thiazide decreases when used in combination with cholestyramine and colestipol.

Spironolactone supplied with ammonium chloride or cholestyramine has been reported to cause hyperkalemic metabolic acidosis.

Additional information on

specific populations An interaction study of specific populations has not been conducted.

Pediatric population

An interaction study of the pediatric population has not been performed.

4.6. Pregnancy and lactation

General recommendation

Pregnancy category: C

Women with childbearing potential / Contraception The

safety of ALDACTAZIDE®in pregnancy has not yet been established.

For this reason, birth control may be considered during the treatment period for women with childbearing potential.

Pregnancy:

Spironolactone

teratogenic effects were observed in studies on mice. In rabbits given spironolactone, reduction in pregnancy rate, increase in resorption rates and decrease in the number of live births were observed. No embryotoxic effects were observed in high-dose spironolactone rats. However, in male rat fetuses, there was a decrease in plasma prolactin level and ventral prostate and seminal vesicle weight in a dose-dependent manner, while it was reported that the luteinizing hormone was more secreted in the female fetuses and an increase in ovarian and uterine weight was observed. In another study performed on rats, feminization was observed in male rat fetuses.

No studies were performed on pregnant women.

Hydrochlorothiazide:

Reproduction toxicity was not found in pregnant mice and rats given hydrochlorothiazide. Thiazide group diuretics may decrease placental perfusion by passing through the placental barrier and may cause uterine laziness to prevent birth.

Studies on the use of thiazide diuretics especially in the first trimester of pregnancy are limited. According to the effect of the pharmacological mechanism of thiazides, diuretics in this group may increase the risk of placental perfusion in the first two and first three months of pregnancy and may cause fatal and neonatal effects such as jaundice, fluid-electrolyte balance deterioration and thrombocytopenia.

Thiazide group diuretics should not be used in patients with congenital edema, hypertension or preeclampsia due to decreased plasma volume and increased risk of placental hypoperfusion.

Thiazides should not be used except in exceptional conditions in which pregnant women with essential hypertension cannot be identified with another treatment option.

Animal studies are insufficient in terms of the effects on pregnancy and-or embryonal / fetal development and-or birth and / or postnatal development. The potential risk for humans is unknown.

The use of ALDACTAZIDE®in pregnancy should be after the benefit-risk assessment for mother and fetus. ALDACTAZIDE should not be used during pregnancy unless necessary.

Lactation

Spironolactone:

The main active metabolite of spironolactone, kanrenon, was detected in breast milk.

Hydrochlorothiazide:

thiazide diuretics were observed in small amounts in breast milk. Thiazides taken in high doses may prevent milk secretion due to excessive diuresis. The ALDACTAZIDEduring breastfeeding® use ofis not recommended. If ALDACTAZIDE is used during lactation, doses should be kept as low as possible or an alternative method for infant feeding should be determined.

Fertility

Spironolactone:

Spironolactone applied to the female mouse reduced fertility. The potential risk for humans is unknown.

Hydrochlorothiazide: Hydrochlorothiazide

administered to mice and rats did not affect fertility. The potential risk for humans is unknown.

4.7. Effects on driving and machine use

Some patients have reported drowsiness and dizziness. Patients should be warned to be careful about activities such as vehicle and machine use.

8.4. Adverse effects

Adverse effects by system-organ class: Very common (>1/10); common (>1/100, <1/10); non-widespread ( > 1/1000, <1/100); infrequently (><span style="font-size:11pt;font-